DEFINITION of INTERNAL
AUDITING
(IIA)
It is an independent, objective assurance and
consulting activity designed to add value
and improve an organization’s operations.
It helps an organization accomplish its objectives
by bringing a systematic, disciplined approach to
evaluate and improve the effectiveness of risk
management, control, and governance processes

 It is a documented and systematic tool
 It should be done periodically by
 independent
“Audit" itself and qualified people
is a checking system. DEFINITION
 “Internal Audit" is an independent
examination of a quality system
 It measures the effectiveness of an
organisation's quality management
system. All personnel have to understand
and do their jobs well
. NOT a
quality assessment
 As a communication tool of management
policies.

BENEFITS OF IA
 Tells you the health of a quality
system
 Identify the root of a problem and
plan for corrective and preventive
actions with timeline
 Achieve better allocation of
resources
 Able to avoid potentially big problem
 Learn what an auditors look for
 Continuous improvement
.

management. RELATIONSHIP of INTERNAL and EXTERNAL
AUDITORS
Differences
The
The external
external auditor
auditor is
is responsible
responsible
to
to financial
financial statement
statement users.
The
The internal
internal auditor
auditor is
is responsible
responsible
to
to management.
.
users.

RESOURCES FOR IA
Considerations should be given to the
following:
 Resources
 Audit techniques
 Processes to achieve and maintain the
competency of auditors and to improve
their performance
 Competency and availability of auditor
 Available time for auditing
.

IA IMPLEMENTATION
The implementation of IA program
consists of :
 Scheduling audit
 Implementation of audit program
 Audit record and report
.

. IA MONITORING
• Implementation of audit program should
be monitored at appropriate intervals
and reviewed to assess whether its
objectives have been met and identified
opportunities for improvement.
• Auditing findings should be reported to
the management.

AUDIT DOCUMENTATION
• Audit plan
 should be sent to auditee prior to
audit activity
 findings from the last audit should be
also mentioned
• Audit note should include
an audit questionnaire
all records and comments during
the audit
• Audit report is an
 official document to report the audit
findings
.

EXAMPLE OF AN AUDIT
CHECKLIST
• General format for an audit checklist
.

Does the company have a work instruction
to operate the machine?
2. How is the machine being cleaned and
maintained?
3.How often is the equipment being calibrated
and cleaned?
5. IA MONITORING
INTERNA: AUDIT QUESTIONAIRES
Area audited : ______________________ Date: __________________
Question (QSR-GMP Reference) Response
1. Are personnel trained to use the machine?
4. When is the last breakdown of the machine?
Are there any product being affected?
.

AUDITING ACTIVITIES (1)
• Conducting on-site audit
activities
 Conduct opening meeting
 Good communication during the
audit
 Roles of escort and observer
 Steps in conducting on site audit:
 Interviews with different personnel
 Carry out both horizontal and vertical
audits.
 Use “Trace-back” method
. Focus on safety and
quality of product.

ISOLATED VERSUS SYSTEMIC DEFICIENCY
NON CONFORMANCE DEFICIENCIES
ISOLATED SYSTEMIC
Latex gloves rip SOP contains an error
Wrong expiration date written on a Batch record is poorly written so
reagent bottle instruction can be confusing
Operator or lab technician spills a Area management does not
sample reinforce requirement to continually
record information properly
Pressing machine of eye shadow Preventive maintenance program
burns out does not include liquid filling
machine motor
.

AUDIT REPORT
 Objectives
 Audit scope
 Identification of audit team
leader and members
 Date and place where the on-
site audit activities were
conducted
 Audit criteria and findings
 Conclusions
.

audit plan. management or
auditee)
 Usually include name and location of
auditee. AUDIT REPORT
 Various formats can be used depending on
auditee (vendors. recommendations or
expectations
 Should write against a standard
 Focus on deficient conditions and not
people
 Include any positive observations
. audit
observations. classification of non-
compliances. date of audit.

4. 2.1 Inadequate Major or Productio Herman Ida
control over sub.Re Findings of IA Gradin Location Auditee Auditor
f g
1.1 Production and Critical Human Abas Budi
QC departments Resources
are headed by
the same person
2.3 Monitoring of Major or Warehous Tuti May Lin
temperature in a Minor e
warehouse
3 11.1. Minor n
contractor
.AUDIT REPORT: AN EXAMPLE
No GMP.

.
It is a means to have
continuous
improvement
.CONCLUSIONS
Nobody likes to be
audited……….